BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 3152596 · Received June 5, 2013

    Report

    Report Number
    1610287-2013-00017
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ALCON - FORT WORTH / ALCON LABS, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED A PATIENT INJURY THAT THE SURGEON THOUGHT MIGHT BE RELATED TO THE GAS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE RISK MANAGER WHO REPORTED THAT DURING A VITRECTOMY PROCEDURE, THERE WAS INJECTION OF GAS MIXED WITH AIR. ON POSTOPERATIVE DAY ONE, THE PATIENT PRESENTED WITH INTRAOCULAR EYE PRESSURE BETWEEN 50-60 MMHG WHILE THE NORMAL IS IN THE 20S. THE SURGEON EXTRACTED 0.6 TO 0.7 CCS OF GAS OUT OF THE EYE. ON POSTOPERATIVE DAY TWO, THE PATIENT'S EYE PRESSURE WAS BACK IN THE 60S MMHG. THE PATIENT UNDERWENT A SECONDARY SURGICAL PROCEDURE FIVE DAYS LATER FOR A VITRECTOMY AND GAS REMOVAL. THE PATIENT WAS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247877 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO ALCON - FORT WORTH / ALCON LABS, INC. NA 117603

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention